Date of Publication :20th May 2021

Abstract: Stability indicating reverse phase-high performance liquid chromatographic method is developed for the estimation of Betrixaban, an oral anticoagulant in formulation. HPLC separation was performed for the drug on the Hi-Q Sil C-18 column, 250 mm × 4.6 mm, 5.0 µ. A very simple mobile phase was used containing methanol: water (80: 20) v/v with a flow rate of 0.7 mL/min and analyte was examined at 272 nm by means of photodiode array (PDA) detector. Retention time of Betrixaban was found to be 2.91 min. For linearity study, the concentration range selected was 10-90 µg/mL and the calibration graph displayed a linear curve over the concentration vs area plot. The mean value of the correlation coefficient was 0.9998, slope was 8581.9 and intercept was 1989.1. The limit of detection (LOD) was 0.5980 µg/mL and limit of quantitation (LOQ) was 1.7381 µg/mL. RP-HPLC method was successfully applied to capsule formulation, no interference of drug and excipients was observed. The method was successfully validated as per ICH guideline in terms of precision, recovery and robustness. In stability studies, Betrixaban was exposed to various stressors; viz: acid, alkali, neutral, oxidation, photo degradation and dry heat. Betrixaban has shown more than 5 % degradation in alkaline, acidic, neutral and photo degradation studies; whereas it is showing less than 5 % degradation in oxidative and dry heat condition. The developed method being very simple and accurate can be applied for routine analysis of Betrixaban in pure and capsule formulation.

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